Saffron extract tested as sleep aid in two new studies

In an April 28, 2025, press release, Activ’Inside commented on two new studies involving its saffron extract, Safr’Inside. The studies examine the effect of the patented, full-spectrum extract on sleep support, adding to the extract’s previously demonstrated support for mood and stress.

The first study¹, a preprint, randomized, double-blind, placebo-controlled pilot, examined the effect of the saffron extract on sleep through the gut microbiome-brain axis changes. It involved 52 older adults experiencing sleep difficulties who consumed one 30mg gummy of Safr’Inside per day for four weeks. Changes in sleep were measured through questionnaires and wearable sleep trackers. Additionally, 26 of the participants underwent microbiome analysis. Results included a decrease in PSQI global score, and increase in improvement in the PSQI-derived sleep quality score, and an increase in sleep efficiency percentage compared with the placebo group. Improvements were also seen in sleep initiation and maintenance, and an increase in the abundance of beneficial bacteria was measured. The researchers called for additional studies to further validate the results.

Next, a randomized, double blind, 3 arm, placebo-controlled clinical study² examined the effects of capsules of 20 or 30 mg of Safr’Inside after four weeks. The study, which has not yet been published, involved 165 participants ages 18-65 with sleep disorders. According to the press release, improvements were seen after 21 days with 20 mg of Safr’Inside.

“Sleep is now the most pressing unmet need in the wellness space,” stated Maïté Jeanroy, marketing and communications director at Activ’Inside, in the press release. “These new clinical results open an exciting new chapter for Safr’Inside™, expanding its proven benefits into the realm of natural sleep support.”

On May 13, Activ’Inside will also host Rethinking Sleep Solutions: Unlocking the Gut–Sleep–Brain Axis for a Restful Night, a webinar examining the results from the studies. It will also be present at booth 3D44 at Vitafoods Europe, taking place May 20-22 in Barcelona, Spain.

References

1. Lang, L.; Ditton, A.; Stanescu, A.; Jainani, V.; McArthur, S.; Pourtau, L.; Gaudout, D.; Pontifex, JMG.; Tsigarides, J.; Steward, T.; Sami, S.; Muller, M.; Hornberger, M.; Vauzour, D.; Lazar, AS. A standardised saffron extract improves subjective and objective sleep quality in healthy older adults with sleep complaints: results from the Gut-Sleep-Brain Axis randomised, double-blind, placebo-controlled pilot study DOI: 10.1101/2025.02.20.25322405
2. Federal Institute for Drugs and Medical Devices. Effect of a saffron extract on sleep parameters in healthy adults with poor sleep: a randomized, double blind, 3 arm, placebo-controlled clinical study. https://drks.de/search/en/trial/DRKS00033435/details (accessed 2025-04-29).